2024
Item Response Theory Quantifies the Relationship Between Improvements in Serum Phosphate and Patient‐Reported Outcomes in Adults With X‐Linked Hypophosphatemia
Mehta K, Gosselin N, Insogna K, Barriere O, Quattrocchi E, Hruska M, Marsteller D. Item Response Theory Quantifies the Relationship Between Improvements in Serum Phosphate and Patient‐Reported Outcomes in Adults With X‐Linked Hypophosphatemia. Clinical Pharmacology & Therapeutics 2024, 116: 1343-1351. PMID: 39129452, DOI: 10.1002/cpt.3406.Peer-Reviewed Original ResearchPatient-reported outcomesPatient-reported outcome dataX-linked hypophosphatemiaItem response theory parametersBrief Fatigue Inventory scoreSerum phosphateWestern Ontario and McMaster Universities Osteoarthritis IndexTreatment-induced improvementMcMaster Universities Osteoarthritis IndexTreatment response biomarkersBrief Pain InventoryInventory scoresAssociated with improvementsPain InventoryOsteoarthritis IndexTreatment optimization strategiesDisability scoresPopulation pharmacokinetic-pharmacodynamic modelPhase III studySerum phosphate levelsRare bone diseasesExposure metricsPharmacokinetic-pharmacodynamic modelLongitudinal dataIII studiesHelping ourselves, helping others: the Young Women’s Breast Cancer Study (YWS) – a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger
Rosenberg S, Zheng Y, Ruddy K, Poorvu P, Snow C, Kirkner G, Meyer M, Tamimi R, Schapira L, Peppercorn J, Come S, Borges V, Warner E, Gelber S, Collins L, Winer E, Partridge A. Helping ourselves, helping others: the Young Women’s Breast Cancer Study (YWS) – a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger. BMJ Open 2024, 14: e081157. PMID: 38951008, PMCID: PMC11218027, DOI: 10.1136/bmjopen-2023-081157.Peer-Reviewed Original ResearchConceptsYoung Women's Breast Cancer StudyMultisite prospective cohort studyBreast Cancer StudyProspective cohort studyStage 0-IV breast cancerBreast cancerCohort studyOlder womenDied of breast cancerFear of recurrencePatient-reported outcome dataYoung womenCancer studiesClinical data abstractionPost-traumatic stressQuality of lifeImprove careFollow-upPsychosocial outcomesYoung survivorsCommunity sitesBiospecimen collectionUnderstudied populationData abstractionOutcome dataA descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.
Siu L, McQuarrie K, Bidadi B, Liu C, Black C, Wang A, Tao Y, Licitra L, Burtness B, Tahara M, Rischin D, Harrington K, Machiels J. A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden. Journal Of Clinical Oncology 2024, 42: 11116-11116. DOI: 10.1200/jco.2024.42.16_suppl.11116.Peer-Reviewed Original ResearchPatient-reported outcomesChemoradiation therapyLA-HNSCCPain killersTumor locationSymptom burdenSolid foodTime of data cut-offPRO scoresQLQ-C30Baseline patient-reported outcomesLocally advanced headPrimary tumor locationData cut-offBaseline PRO scoresWeight lossPatient-reported outcomes analysisBaseline item scoresAssociated with high symptom burdenInvestigating pembrolizumabPatient-reported outcome dataAdvanced headHigh symptom burdenDouble-blindEvent-freeToward a more patient‐centered drug development process in clinical trials for patients with myelodysplastic syndromes/neoplasms (MDS): Practical considerations from the International Consortium for MDS (icMDS)
Efficace F, Buckstein R, Abel G, Giesinger J, Fenaux P, Bewersdorf J, Brunner A, Bejar R, Borate U, DeZern A, Greenberg P, Roboz G, Savona M, Sparano F, Boultwood J, Komrokji R, Sallman D, Xie Z, Sanz G, Carraway H, Taylor J, Nimer S, Della Porta M, Santini V, Stahl M, Platzbecker U, Sekeres M, Zeidan A. Toward a more patient‐centered drug development process in clinical trials for patients with myelodysplastic syndromes/neoplasms (MDS): Practical considerations from the International Consortium for MDS (icMDS). HemaSphere 2024, 8: e69. PMID: 38774655, PMCID: PMC11106800, DOI: 10.1002/hem3.69.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsPatient-reported outcomesPatient-reported outcome dataHealth-related qualityPatient-reported outcome endpointsHealth-related quality of lifeClinical trialsImprove patients' health-related qualityPatients' health-related qualityPatient-reported outcome itemsQuality of lifeTime-to-event analysisRandomized Controlled TrialsTreatment decision-makingPatient carePatient populationTreatment advancesControlled TrialsPatientsIncurable diseaseAssessment strategiesHRQoLBenefit/risk assessmentDrug development processTrialsTherapy
2023
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory
Zigler C, Adeyemi O, Boyd A, Braciszewski J, Cheville A, Cuthel A, Dailey D, Del Fiol G, Ezenwa M, Faurot K, Justice M, Ho P, Lawrence K, Marsolo K, Patil C, Paek H, Richesson R, Staman K, Schlaeger J, O'Brien E. Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory. Contemporary Clinical Trials 2023, 137: 107426. PMID: 38160749, PMCID: PMC10922303, DOI: 10.1016/j.cct.2023.107426.Peer-Reviewed Original ResearchPatient-reported outcome measuresElectronic health recordsPragmatic clinical trialsOutcome measuresHealth recordsClinical trialsHealth system's electronic health recordPatient-reported outcome dataOutcome measure selectionLow-resource settingsSecondary outcomesOutcome dataResource settingsLack of consensusStudy teamTrialsSystem prioritiesRecordsCliniciansAdministrationMeasures
2020
Patient-Reported Outcome Measures in Colon and Rectal Surgery: A Systematic Review and Quality Assessment.
Hawkins AT, Rothman RL, Geiger TM, Canedo JR, Edwards-Hollingsworth K, LaNeve DC, Penson DF. Patient-Reported Outcome Measures in Colon and Rectal Surgery: A Systematic Review and Quality Assessment. Diseases Of The Colon & Rectum 2020, 63: 1156-1167. PMID: 32692077, PMCID: PMC8029646, DOI: 10.1097/dcr.0000000000001717.Peer-Reviewed Original ResearchConceptsPatient-reported outcome measuresOutcome measuresColorectal surgeryColorectal surgical interventionsPatient-reported outcome dataSurgical intervention increasesNumber of patientsComparative effectiveness analysisRobust measurement propertiesValue-based careSurgical interventionCase reportRectal surgeryInclusion criteriaExclusion criteriaLiteracy levelsOutcome dataSurgerySystematic reviewColorectal researchIntervention increasesMajor databasesMeasurement properties
2019
Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance)
Sharma MR, Mehrotra S, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno‐Aspitia A, Lad TE, Velasco M, Overmoyer B, Rugo HS, Ratain MJ, Gobburu JV. Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance). The Journal Of Clinical Pharmacology 2019, 60: 444-452. PMID: 31802506, PMCID: PMC7064382, DOI: 10.1002/jcph.1559.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAlgorithmsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsComputer SimulationDrug Administration ScheduleDrug TaperingEpothilonesFemaleHumansModels, BiologicalPaclitaxelPatient Reported Outcome MeasuresPeripheral Nervous System DiseasesPrecision MedicineConceptsDose-adjustment algorithmPatient-reported outcome dataEarly time pointsNeuropathy scoreDose adjustmentNanoparticle albuminIndividual patientsTime pointsOutcome dataChemotherapy-induced peripheral neuropathyRandomized phase III trialFirst-line chemotherapyMetastatic breast cancerPhase III trialsPatient-reported outcomesRedefining chemotherapy-induced peripheral neuropathy through symptom cluster analysis and patient-reported outcome data over time
Wang M, Cheng H, Lopez V, Sundar R, Yorke J, Molassiotis A. Redefining chemotherapy-induced peripheral neuropathy through symptom cluster analysis and patient-reported outcome data over time. BMC Cancer 2019, 19: 1151. PMID: 31775665, PMCID: PMC6882224, DOI: 10.1186/s12885-019-6352-3.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCluster AnalysisFemaleHumansLongitudinal StudiesMaleMiddle AgedNeoplasm StagingNeoplasmsPatient Reported Outcome MeasuresPeripheral Nervous System DiseasesPublic Health SurveillanceQuality of LifeSurveys and QuestionnairesSymptom AssessmentConceptsSymptom clustersCancer Quality of Life Questionnaire CoreTreatment of Cancer Quality of Life Questionnaire CoreQuality of Life Questionnaire CoreImprove symptom managementPatient-reported outcome dataBackgroundChemotherapy-induced peripheral neuropathySymptom management strategiesMethodsA secondary analysisSymptom cluster analysisNeurotoxic chemotherapy agentsEuropean Organization for the ResearchSymptom managementChemotherapy-induced peripheral neuropathySecondary analysisResultsSample sizeCancer diagnosisAssessment pointsPeripheral neuropathyOutcome dataCIPNClinical practiceThe ResearchFollow-upSecondary symptoms
2018
The Scleroderma Patient-Centered Intervention Network Cohort: baseline clinical features and comparison with other large scleroderma cohorts
Dougherty DH, Kwakkenbos L, Carrier ME, Salazar G, Assassi S, Baron M, Bartlett SJ, Furst DE, Gottesman K, van den Hoogen F, Malcarne VL, Mouthon L, Nielson WR, Poiraudeau S, Sauvé M, Boire G, Bruns A, Chung L, Denton C, Dunne JV, Fortin P, Frech T, Gill A, Gordon J, Herrick AL, Hinchcliff M, Hudson M, Johnson SR, Jones N, Kafaja S, Larché M, Manning J, Pope J, Spiera R, Steen V, Sutton E, Thorne C, Wilcox P, Thombs BD, Mayes MD, Albert A, Arsenault G, Bissonette L, Boutron I, Carreira P, Maia A, Dagenais P, Domsic R, El-Baalbaki G, Ells C, van den Ende C, Fligelstone K, Fortune C, Godard D, Gyger G, Harel D, Ikic A, Impens A, Jang Y, Artur Jose de B, Kennedy A, Khalidi N, Korman B, Leite C, Liang P, Marra C, Masetto A, Nielsen K, Portales A, Riggs R, Reyna T, Roux S, Schouffoer A, Steele R, Suarez-Almazor M, Varga J, Welling J, Wigley F, Wong-Rieger D, Cumin J, Delisle V, Fedoruk C, Fox R, Gholizadeh S, Jewett L, Levis B, Mills S, Pepin M, Persmann J, Turner K. The Scleroderma Patient-Centered Intervention Network Cohort: baseline clinical features and comparison with other large scleroderma cohorts. Rheumatology 2018, 57: 1623-1631. PMID: 29868924, DOI: 10.1093/rheumatology/key139.Peer-Reviewed Original ResearchConceptsIntervention Network CohortSPIN CohortSSc cohortAntibody frequencyCanadian Scleroderma Research Group cohortBaseline clinical featuresEuropean Scleroderma TrialsLarge SSc cohortPatient-reported outcome dataSSc renal crisisInterstitial lung diseasePatient-reported outcomesWeb-based cohortRenal crisisScleroderma cohortDcSSc patientsScleroderma TrialsOrgan involvementWhite patientsClinical featuresHigher proportionLung diseaseScleroderma patientsHigh prevalenceOutcome data
2015
The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial
Vardi M, Cryer BL, Cohen M, Lanas A, Schnitzer TJ, Lapuerta P, Goldsmith MA, Laine L, Doros G, Liu Y, McIntosh AI, Cannon CP, Bhatt DL. The effects of proton pump inhibition on patient‐reported severity of dyspepsia when receiving dual anti‐platelet therapy with clopidogrel and low‐dose aspirin: analysis from the Clopidogrel and the Optimization of Gastrointestinal Events Trial. Alimentary Pharmacology & Therapeutics 2015, 42: 365-374. PMID: 26032114, PMCID: PMC4494867, DOI: 10.1111/apt.13260.Peer-Reviewed Original ResearchConceptsDual anti-platelet therapyAnti-platelet therapyGastrointestinal Event TrialLow-dose aspirinNonpain symptomsEvents trialPatient-reported outcome dataPercent of patientsPatient-reported symptomsPatient-reported outcomesPatient-reported severityOmeprazole groupProphylactic omeprazoleCardiovascular safetyGastrointestinal bleedingPain intensityClinical eventsOmeprazole useClinical significanceOutcome dataAssessment QuestionnaireClopidogrelDyspepsiaTherapyPatients
2009
Differential Symptom Reporting by Mode of Administration of the Assessment
Sikorskii A, Given CW, Given B, Jeon S, You M. Differential Symptom Reporting by Mode of Administration of the Assessment. Medical Care 2009, 47: 866-874. PMID: 19584761, PMCID: PMC2722377, DOI: 10.1097/mlr.0b013e3181a31d00.Peer-Reviewed Original ResearchConceptsNurse armSymptom managementMode of administrationIntervention contactsSymptom reportingTelephone interviewsPatient-reported outcome dataCancer-related symptomsSymptom management strategiesSymptom management interventionsHigher severityPoor appetitePatient reportingCancer patientsSymptom assessmentClinical trialsSymptom monitoringOutcome dataPatientsClinical practiceSolid tumorsVoice response systemOlder groupSymptomsIntake interview
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